{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2026-20742", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260408", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20260101", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "RISK MANAGER", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260408", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250918", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "881697", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260408", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-16", "catalog_number": "400180", "lot_number": "K14250918", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)K14250918", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260408", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "67 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260408", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24818168", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260312", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "397800262", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A ROBOTIC-ASSISTED CYSTECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT LOOSENED WHILE INSIDE THE PATIENT¿S ABDOMEN. THE SCRUB TECHNICIAN NOTICED THE ISSUE IMMEDIATELY, SO THE SURGEON DID NOT ACTIVATE THE INSTRUMENT. THE SCRUB TECHNICIAN THEN REMOVED THE MCS INSTRUMENT, WHICH CAUSED THE TIP COVER ACCESSORY TO DETACH COMPLETELY. HOWEVER, IT IS UNKNOWN IF THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT AND WAS RETRIEVED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT. ON 12-MAR-2026, ISI RECEIVED MEDWATCH REPORT (MDR) WITH REPORT (B)(4) STATING: \"WHILE SURGERY WAS IN PROGRESS; ROBOTIC CYSTECTOMY, THE MONOPOLAR SCISSORS ACCESSORY TIP COVER CAME LOOSE WHILE THE INSTRUMENT WAS INSIDE PATIENT'S ABDOMEN. IT WAS NOTICED RIGHT AWAY BY THE SCRUB TECH; THUS, ACTIVATION OF THE MONOPOLAR SCISSORS WAS NOT INITIATED BY SURGEON. THE SCRUB TECH REMOVED THE MONOPOLAR SCISSORS FROM THE ENDOWRIST THAT CAUSED THE TIP TO COME OFF COMPLETELY FROM THE SCISSORS.\"" }, { "mdr_text_key": "397800263", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A LOG REVIEW CANNOT BE PERFORMED DUE TO INSUFFICIENT EVENT INFORMATION PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }